What’s All the Fuss About F/TAF? A Trailer for Action in 2020

What’s all the fuss about F/TAF for oral PrEP? The US Food and Drug Administration (FDA) approved drug maker Gilead’s Descovy (also known as F/TAF) as daily oral PrEP in October 2019, with one notable caveat: the label excluded those who are at risk from “receptive vaginal sex”, indicating that more data is needed for the drug to be approved as HIV prevention for cisgender women. The FDA’s supplemental approval requires Gilead to conduct safety and efficacy trial in cisgender women on a timeline that aims for data by 2025.

In the aftermath of this approval, there are questions about the differences between these two forms of PrEP, what contribution F/TAF might make to the pipeline of prevention, and the vital role of stakeholder engagement as Gilead drafts the study protocol for a trial of F/TAF in women. We explore all this and more in this episode of Px Pulse.

Materials

AVAC Report 2019: One-pager

Each year, the AVAC Report frames the most pressing advocacy issues facing the HIV response. At the threshold of 2020, it’s clear that global goals for HIV prevention will miss the mark by a long shot. Now what?

This is a one-pager summarizing AVAC’s priorities for 2020. To download the full Report or see all its graphics, visit report.avac.org.

AVAC’s “3D” View of the World: 2019 and beyond

This infographic lays out AVAC’s top-line recommendations from AVAC Report 2019: Now What? The recommendations fall into three categories: deliver — prevention programs whose impact is well-measured and -defined; demonstrate — next-generation engagement for next-generation trials; develop — new targets for the post-2020 world.

UNAIDS Fast-Track Targets: The plan and the progress

The most widely-known UNAIDS Fast-Track goals were the 90-90-90 targets focused on diagnosing people with HIV, linking them to ART and supporting them to achieve virologic suppression. But these were only part of what the UNAIDS modelers said was needed to reduce new HIV diagnoses to 500,000 per year; the model also included significant scaling up of primary prevention including the targets listed below. There are gaps across the board, which helps explain how the world fell short of the hoped-for reduction in new HIV diagnoses.

Excerpted from AVAC Report 2019: Now What?

Declines but Not a Decisive Effect of the Intervention

UNAIDS’ Fast-Track Goals for ending the epidemic focused on testing 90 percent of people living with HIV, linking 90 percent of those people to ART, and supporting 90 percent of those individuals to reach virologic suppression. This busy figure summarizes recent research on how reaching these targets impacts incidence.

Each orange arrow shows the level of virologic suppression among PLHIV in the community at the start and end of the trial, the pairs of arrows represent different trial arms. The figure in the box above is the absolute difference in suppression between the two arms. For PopART, which had three arms, there are two different comparisons. The longer arrows belong to the intervention arms, which had a greater increase in virologic suppression across the trials. The blue bars show the point estimate for, and confidence interval around, the relative incidence in the intervention arm compared to the control arm. The bottom line: arms with community-wide testing saw incidence drop. Rapid expansion of ART leading to virologic suppression is feasible. This is good news for communities and individuals.

Excerpted from AVAC Report 2019: Now What?

A Generic and Unifying HIV Prevention Cascade Framework

What get’s measured matters if and only if that measurement is linked to impact. The most common approaches to evaluating primary prevention don’t measure up. They measure commodities but not use. A count of the condoms or PrEP bottles handed to people does not tell you whether the condoms were used, the pills were taken—or even, often, whether the people receiving the commodities were at high risk of HIV. A simple, universal prevention cascade could help change that. This one, which presumes that HIV testing has happened and is focused on people at risk of HIV, suggests four stages (see A) and then shows how solutions could be tailored to fix the cascade (see B).

Excerpted from AVAC Report 2019: Now What?

Monitoring Primary Prevention: What to look at and why it matters – for oral PrEP and more

A look at four major factors relevant to primary prevention and correlated interventions to support their impact.

Excerpted from AVAC Report 2019: Now What?

What Gets Measured Matters

There is enormous variability in country and funder/normative approaches to tracking PrEP program rollout. Assessments of progress require common, comprehensive measures against and estimates of the parameters seen here.

Excerpted from AVAC Report 2019: Now What?

Total and Additional Users of Modern Contraception, 2012-2019

In November 2019, FP2020 released Women at the Center: 2018-2019, its latest progress report from which this graphic is adapted. As its graphic below shows, coverage of modern contraception in the 69 low-income countries that partner with FP2020 in tracking progress has increased since 2012, but not at the pace needed to meet the FP2020 goal. The group has also launched a post-2020 vision, and AVAC looks forward to working together towards an integration agenda.

Excerpted from AVAC Report 2019: Now What?

Metrics for Epidemic Transition: A glossary

Following the 2016 UN High-Level Meeting on HIV/AIDS, UNAIDS undertook work to derive a better definition of what “epidemic control” might look like and how it might be measured. It turns out that out saying the era of seeking the “end of the AIDS epidemic”—a phrase from a few years back—has come to an end. It’s rhetorically powerful but tricky to pin down what this means. Countries and communities need better, more precise ways to track progress. Funders need this information too, in order to see impact and sustain confidence in the effort. With great global diversity in incidence and mortality rates, worldwide measures obscure progress and challenges.

This table summarizes the work to date on identifying metrics that make sense for tracking the epidemic. Civil society must weigh in on what matters to us, which of these terms is meaningful and how to minimize the potential for manipulation and misinterpretation.

Excerpted from AVAC Report 2019: Now What?